(60 days)
The In2Bones Ankle Fusion plating system is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.
The addition of a compression screw through the tibiotalar joint (example IBS™ 6.5mm screw) is required.
The Ankle Fusion Plating System is composed of an anatomically contoured plate, with a distal part adapted to the talar neck, and a proximal part adapted to the distal tibial epiphysis and diaphysis. Rigid fixation is achieved by screws.
The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V. A dedicated instrument set is available for the bone preparation, screw sizing and insertion of the Ankle Arthrodesis Plating System. A specific targeting device is available for the insertion of the additional I.B.S® 6.5mm screw.
Sizes: The Ankle Fusion Plate is available in one size, with left and right versions. Fixation screws are available in 3.5 or 4.5mm diameter, with length ranging from 10 to 100mm.
Material: The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V, as per ISO 5832-1 and ASTM F136.
Single use: The Ankle Fusion Plating System is designed for single use only.
Sterilization: The Ankle Fusion Plating System is supplied sterile, using gamma irradiation.
Place of use: The Ankle Fusion Plating System is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
I am sorry, but the provided text does not contain the detailed information needed to answer your request regarding acceptance criteria and a study proving device performance on an AI/ML device.
The document is a 510(k) premarket notification letter from the FDA for an "Ankle Fusion Plating System," which is a metallic bone fixation appliance, not an AI/ML device.
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size and data provenance for an AI/ML test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for an AI/ML test set.
- Multi-reader multi-case comparative effectiveness study results for AI assistance.
- Standalone performance of an algorithm.
- Type of ground truth for an AI/ML device.
- Sample size for an AI/ML training set.
- How ground truth for an AI/ML training set was established.
The "Summary Performance Data" section in the document broadly states: "Performance testing of the Ankle Fusion Plating System was assessed through mechanical bench testing performed by an independent test laboratory, animal and clinical testing being considered not applicable. Testing performed included static and dynamic compression tests on Ankle Fusion Plating System. The results indicate that the Ankle Fusion Plating System met the acceptance criteria." This refers to mechanical testing of a physical implant, not an AI/ML system.
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November 28, 2017
In2Bones SAS % Ms. Christine Scifert Executive Vice President MRC-X, LLC 6075 Poplar Ave, Suite 500 Memphis, Tennessee 38119
Re: K173121
Trade/Device Name: Ankle Fusion Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: September 27, 2017 Received: September 29, 2017
Dear Ms. Scifert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173121
Device Name Ankle Fusion Plating System
Indications for Use (Describe)
The In2Bones Ankle Fusion plating system is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.
The addition of a compression screw through the tibiotalar joint (example IBS™ 6.5mm screw) is required.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K173121 Page 1 of 3
| Sponsoridentification | In2Bones SAS28 chemin du Petit Bois69130 Ecully – FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29 |
|---|---|
| Establishmentregistration number | 3010470577 |
| Date of preparation | November 8, 2017 |
| Contact person | Christine Scifert, MS, MEMMRC-X, LLC6075 Poplar Avenue, suite 500Memphis, TN 38119Cell: 901-831-8053Email: Christine.Scifert@mrc-x.com |
| Proprietary Name | Ankle Fusion Plating System |
| Common name | Ankle Fusion Plating System |
| Deviceclassificationregulation | 21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessoriesClass II |
| Device ProductCode and Panel | HRS: plate, fixation, boneHWC: screw, fixation, bone87 orthopedics |
| Device Description | The Ankle Fusion Plating System is composed of ananatomically contoured plate, with a distal part adapted to thetalar neck, and a proximal part adapted to the distal tibialepiphysis and diaphysis. Rigid fixation is achieved by screws. |
| The Ankle Fusion Plating System implants (plate and screws) aremanufactured from Ti6Al4V. A dedicated instrument set isavailable for the bone preparation, screw sizing and insertion ofthe Ankle Arthrodesis Plating System. A specific targetingdevice is available for the insertion of the additional I.B.S®6.5mm screw. | |
| Sizes:The Ankle Fusion Plate is available in one size, with left andright versions.Fixation screws are available in 3.5 or 4.5mm diameter, withlength ranging from 10 to 100mm. | |
| Material: The Ankle Fusion Plating System implants (plate andscrews) are manufactured from Ti6Al4V, as per ISO 5832-1 andASTM F136. | |
| Single use: The Ankle Fusion Plating System is designed forsingle use only. | |
| Sterilization: The Ankle Fusion Plating System is suppliedsterile, using gamma irradiation. | |
| Place of use: The Ankle Fusion Plating System is indicated foruse in a hospital, or outpatient surgery center where sterile fieldmay be created and maintained. | |
| Predicate Devices | Primary Predicate:Tibiaxys (K073375), Newdeal, Acquired by IntegraLifeSciences |
| Additional Predicates:Peri-Loc Ankle Fusion Plating System (K083032), Smith andNephewAnkle Fusion Plating System (K141735), ArthrexExtremiLock Ankle Fusion Plating System (K133691),OsteomedLCP Ankle Arthrodesis Plate (K022255), SynthesOrtholoc3Di Ankle Fusion Plating system (K121425), WMT | |
| Indications for use: | The In2Bones Ankle Fusion plating system is indicated foranterior fixation of ankle arthrodesis and fractures, including thedistal tibia, talus and calcaneus.The addition of a compression screw through the tibiotalar joint(example IBSTM 6.5mm screw) is required. |
| Comparison of theindications for usewith the predicatedevices: | The indications for use for the In2Bones Ankle Fusion PlatingSystem are similar to the predicate devices Newdeal Tibiaxys(K073375), Smith and Nephew Peri-Loc Ankle Fusion PlatingSystem (K083032), Arthrex Ankle Fusion Plating System(K141735), Osteomed ExtremiLock Ankle Fusion PlatingSystem (K133691), Synthes LCP Ankle Arthrodesis Plate(K022255), and Wright Medical Ortholoc3Di Ankle FusionPlating system (K121425) |
| Comparison ofTechnologicalcharacteristics andSubstantialEquivalenceSummary: | The In2Bones Ankle Fusion Plating System is similar to thepredicate devices Newdeal Tibiaxys (K073375), Smith andNephew Peri-Loc Ankle Fusion Plating System (K083032),Arthrex Ankle Fusion Plating System (K141735), OsteomedExtremiLock Ankle Fusion Plating System (K133691), SynthesLCP Ankle Arthrodesis Plate (K022255), and Wright MedicalOrtholoc3Di Ankle Fusion Plating system (K121425) inintended use, design, size ranges, principle of operation andmaterials. |
| SummaryPerformance Data | Performance testing of the Ankle Fusion Plating System wasassessed through mechanical bench testing performed by anindependent test laboratory, animal and clinical testing beingconsidered not applicable.Testing performed included static and dynamic compressiontests on Ankle Fusion Plating System. The results indicate thatthe Ankle Fusion Plating System met the acceptance criteria. |
| Pyrogen testing | The method used to make the determination that the device meetspyrogen limit specification is the Limulus Amebocyte Lysate(LAL) test in accordance with ANSI/AAMI ST72:2011:Bacterial endotoxins - Test methods, routine monitoring andalternative to batch testing. |
| CONCLUSION | Based on the comparison of indications for use andtechnological characteristics and the results of the testingperformed, the Ankle Fusion Plating System is substantiallyequivalent to the predicate devices identified in the 510(k)submission. |
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.